Ora’s pre-clinical and clinical models, unique clinical methodologies and regulatory experience as well as expertise, have been refined and proven across thousands of projects both in the US and internationally. We bring together the world’s most extensive and experienced network of ophthalmic experts and R&D professionals to maximize the value of new product initiatives.
Ora Japan is the local regulatory and clinical operations center for Ora, the world’s leading ophthalmic development services provider. Ora Japan is located in downtown Osaka and Tokyo, within the heart of Japan’s biotech corridor.
Clinical Models, Endpoints, and Scales
Ora is the leading pharmaceutical and device services expert in all indications of the eye, including the front and back of the eye. We have developed validated clinical models that are accepted as regulatory endpoints in allergic conjunctivitis (Ora-CAC® model), dry eye (CAE®) and inherited retinal diseases (Ora-VNC™ mobility course). We will collaborate with you to design the optimal study and the associated endpoints to accelerate your timelines and achieve the goal of your program.
Ora has partnered with many companies to develop novel anti-allergic products efficiently and reliably in Japan. It uses its Ora-CAC® model, as well as other models to our partner’s benefit. Ora uses its standard CAC® (e.g. anti-histamine) and modified CAC® (e.g. anti-inflammatory) to accelerate the development of innovative therapies with a broad range of mechanism of actions. Ora has partnered with the Kitasato Institute to bring the standard Ora-CAC® allergy models to Japan and integrating with the experimental operations at Kitasato Institute.
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